Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol

: Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products.

When and how to update systematic reviews.

BACKGROUND: Systematic reviews are most helpful if they are up-to-date. We did a systematic review of strategies and methods describing when and how to update systematic reviews. OBJECTIVES: To identify, describe and assess strategies and methods addressing: 1) when to update systematic reviews and 2) how to update systematic reviews. SEARCH STRATEGY: We searched MEDLINE (1966 to December 2005), PsycINFO, the Cochrane Methodology Register (Issue 1, 2006), and hand searched the 2005 Cochrane Colloquium proceedings. SELECTION CRITERIA: We included methodology reports, updated systematic reviews, commentaries, editorials, or other short reports describing the development, use, or comparison of strategies and methods for determining the need for updating or updating systematic reviews in healthcare. DATA COLLECTION AND ANALYSIS: We abstracted information from each included report using a 15-item questionnaire. The strategies and methods for updating systematic reviews were assessed and compared descriptively with respect to their usefulness, comprehensiveness, advantages, and disadvantages. MAIN RESULTS: Four updating strategies, one technique, and two statistical methods were identified. Three strategies addressed steps for updating and one strategy presented a model for assessing the need to update. One technique discussed the use of the "entry date" field in bibliographic searching. Statistical methods were cumulative meta-analysis and predicting when meta-analyses are outdated. AUTHORS' CONCLUSIONS: Little research has been conducted on when and how to update systematic reviews and the feasibility and efficiency of the identified approaches is uncertain. These shortcomings should be addressed in future research.

Bisphosphonate therapy for children and adolescents with secondary osteoporosis.

BACKGROUND: Children with chronic illnesses are at increased risk for reductions in bone strength and subsequent fractures (osteoporosis), either due to the impact of the underlying condition on skeletal development or due to the osteotoxic effect of medications (e.g., glucocorticoids) used to treat the chronic illness. Bisphosphonates are being administered with increasing frequency to children with secondary osteoporosis; however, the efficacy and harm of these agents remains unclear. OBJECTIVES: To examine the efficacy and harm of bisphosphonate therapy in the treatment and prevention of secondary osteoporosis in children and adolescents. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (Issue 4, 2006), MEDLINE, EMBASE, CINAHL and ISI Web of Science (inception-December 2006). Further literature was identified through expert contact, key author searches, scanning reference lists of included studies, and contacting bisphosphonate manufacturers. SELECTION CRITERIA: Randomized, quasi-randomized, controlled clinical trials, cohort, and case controls of bisphosphonate(s) in children 0-18 years of age with at least one low-trauma fracture event or reductions in bone mineral density in the context of secondary osteoporosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed quality. Case series were used for supplemental harms-related data. MAIN RESULTS: Six RCTs, two CCTs, and one prospective cohort (n=281 children) were included and classified into osteoporosis due to: 1) neuromuscular conditions (one RCT) and 2) chronic illness (five RCTs, two CCTs, one cohort). Bisphosphonates examined were oral alendronate, clodronate, and intravenous (IV) pamidronate. Study quality varied. Harms data from 23 case series (n=241 children) were used. Heterogeneity precluded statistically combining the results. Percent change or Z-score change in lumbar spine areal BMD from baseline were consistently reported. Two studies carried out between-group analyses; one showed no significant difference (using oral alendronate in anorexia nervosa) while the other demonstrated a treatment effect on lumbar spine with IV pamidronate in burn patients. Frequently reported harms included the acute phase reaction, followed by gastrointestinal complaints, and bone/muscle pain. AUTHORS' CONCLUSIONS: The results justify further evaluation of bisphosphonates among children with secondary osteoporosis. However, the evidence does not support bisphosphonates as standard therapy. Short-term (3 years or less) bisphosphonate use appears to be well-tolerated. An accepted criterion for osteoporosis in children, a standardized approach to BMD reporting, and examining functional bone health outcomes (e.g., fracture rates) will allow for appropriate comparisons across studies.

A dynamic model for assessing universal Hepatitis A vaccination in Canada.

Vaccination against Hepatitis A virus (HAV) in Canada is currently targeted toward high-risk groups. However, universal vaccination has been adopted in several other countries with a similar disease burden. Here we develop an age-structured compartmental model of HAV transmission and vaccination in Canada to assess potential universal vaccination strategies. The model predicts that universal vaccination at age 1 (respectively 4, 9, 15), with phasing out of targeted vaccination, would reduce reported incidence by 60% (respectively 52, 36, 31%) and mortality attributable to HAV by 56% (respectively 45, 26, 25%), relative to continued targeted vaccination, over 80 years.